Clinical Innovation Engineer, Medical Technology Office

KK Women's & Children's Hospital; Singapore; On-site; SGD 45,000 - 70,000; Full time

Job summary

An established industry player is seeking a dynamic individual to support clinical innovation projects in medical technology. This role involves identifying unmet clinical needs, generating solutions, and managing project tasks to ensure timely completion. You will assist with grant applications and compliance documentation while collaborating with the device development team on prototypes. If you have a passion for innovation and a background in engineering or biomedical fields, this is an exciting opportunity to make a significant impact in healthcare.

Qualifications

• 2 years’ experience in medical technology innovation.
• Strong knowledge in regulatory affairs and medical device standards.

Responsibilities

• Assist in identifying and validating clinical needs for innovation projects.
• Coordinate information for grants and manage project tasks.

Skills

Teamwork

Communication Skills

Problem Solving

Technical Writing

IT Skills

CAD Skills

Simulation Skills

Education

Master’s Degree in Engineering

Bachelor’s Degree in Biomedical Engineering

Bachelor’s Degree in Science

Tools

LabView

MatLab

SolidWorks

AutoCad

Job description

You will assist in the identification, validation and selection of unmet clinical needs, as well as participate in solution generation and prototyping. You will conduct testing, create supporting documentation required for patenting and regulatory approval and work with partners on commercialisation strategy.

You will coordinate and compile relevant information for grants and other funding applications, as well as manage and drive project tasks to ensure timely completion of project milestones. You will create relevant documentation, meeting records and support follow-up actions for clinical innovation projects.

You will support the device development team in brainstorming and prototype creation for projects. You will also be involved in general administrative and procurement assistance, and support the department in the program management of med-tech innovation grants including the grant application process, grant award and progress reporting.

You will provide administrative support for innovation training and education initiatives, including planning, implementation, publicity and events.

You will ensure compliance with quality, regulatory and organisation policies and systems, and support record-keeping and documentation needed for compliance.

Requirements

• Master’s / Bachelor’s Degree in Engineering, Biomedical Engineering or Science with preferably 2 years’ experience in medical technology innovation leading the development of concept ideas into products.
• Excellent team work and communication skills.
• Excellent problem solving skills with strong focus in technical writing.
• Strong knowledge in IT, CAD and/or Simulation Skills, e.g. LabView, MatLab, SolidWorks, AutoCad.
• Good knowledge in ISO 13485, ISO14155, Good Clinical Practice (GCP), Regulatory Affairs, Medical Device Standards, Intellectual Property Strategy will be an advantage.
• Knowledge of trial procedures, institutional, Centralised Institutional Review Board and regulatory authority (HSA) requirements will be an advantage.